(1) Reasons for Proposal

In accordance with the enactment of the Act on the Safety and Support of High-Tech Regenerative Medical Service and Advanced Biopharmaceuticals (Act No. 16556, promulgated on Aug. 27, 2019, to enter into force on Aug. 28, 2020), this proposal aims to prescribe matters delegated to lower statutes in the Act and matters necessary for its enforcement.

(2) Major Provisions

A. Define the scope of high-tech regenerative medical service and human cells, and prescribe the criteria and procedures for distinguishing the level of danger in clinical research (Articles 2 through 4)

B. Prescribe, in order to establish a master plan in the competent field, detailed policies, agency in charge of submission, agency in charge of forming a policy committee, method and procedures for establishing plans, etc. (Articles 5 through 9)

C. Determine information and data to be included in action plans on clinical research to be prepared by a regenerative medical service institution wishing to conduct clinical research in high-tech regenerative medical service, and prescribe procedures for the deliberation and approval of research plans by the Deliberation Committee (Article 12)

D. Prescribe terms for Deliberation Committee members and requirements for holding meetings, and prescribe matters subject to deliberation and vote by the Committee and matters subject to advisory opinions (Article 14 and Articles 18 through 20)

E. Establish a committee under the Deliberation Committee to secure efficiency and expertise in deliberation of research plans, and prescribe the organization, management methods, and matters subject to advisory opinions and votes with respect to the committee members (Articles 15 through 16)

F. Establish a secretariat under the Deliberation Committee to process secretarial work related to deliberation of research plans and advisory work on the evaluation of advanced biopharmaceuticals, and prescribe matters regarding the secretariat’s responsibilities and its management (Article 17)

G. Determine, with respect to high-tech regenerative medical cell processing facilities, criteria regarding their facilities, equipment, personnel, and prescribe matters such as written consents and obligation to provide prior notice when obtaining body cells, etc., and matters to be complied with when obtaining xeno-cells, etc. (Articles 21 through 25)

H. Enable safety control institutions to establish and operate clinical research information systems, and prescribe procedures for establishing and confirming plans regarding long-term tracking overseen by safety control institutions (Articles 27 through 28)

I. Prescribe criteria on facilities for manufacturing businesses such as advanced biopharmaceuticals, and determine criteria on facilities of advanced biopharmaceutical importers (Articles 30 through 31)

J. Designate the Korea Institute of Drug Safety and Risk Management as the Regulatory Sciences Center, prescribe the work scope of Regulatory Sciences Centers, and prescribe for doctors, etc., who administer advanced biopharmaceuticals subject to long-term tracking, the obligation to register administration details (Articles 36 and 37)

K. Establish a supervisory institution in the Ministry of Food and Drug Safety for collection, inspection, etc., of body cells, etc., and prescribe the organization, authority, work scope, etc., of such supervisory institution (Article 38)

L. Prescribe criteria for imposing penalty surcharges in lieu of suspension of work as well as the procedures for imposition and collection, and prescribe matters regarding dunning of non-payers of penalty surcharges, measures to be taken in case of default, and suspension of work measures (Articles 40 through 42)